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Insecticides/Pest/Food Additives Detox

DRUG FACTS:

Approved
Approval ID

b5778211-0e3e-44ef-bd65-a76a68cf1504

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Dr. Donna Restivo DC

DUNS: 790796940

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Boldo, Carduus Marianus, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Bisphenol A, Cobaltum Metallicum, Cuprum Metallicum, Glyphosate, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62185-0065
Product Classification
G
Generic Name
Boldo, Carduus Marianus, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Bisphenol A, Cobaltum Metallicum, Cuprum Metallicum, Glyphosate, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (27)

PEUMUS BOLDUS LEAFActive
Quantity: 3 [hp_X] in 1 mL
Code: Q4EWM09M3O
Classification: ACTIB
MILK THISTLEActive
Quantity: 3 [hp_X] in 1 mL
Code: U946SH95EE
Classification: ACTIB
CHELIDONIUM MAJUS WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: 7E889U5RNN
Classification: ACTIB
PETROSELINUM CRISPUM WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: 1WZA4Y92EX
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
BISPHENOL AActive
Quantity: 12 [hp_X] in 1 mL
Code: MLT3645I99
Classification: ACTIB
COBALTActive
Quantity: 12 [hp_X] in 1 mL
Code: 3G0H8C9362
Classification: ACTIB
COPPERActive
Quantity: 12 [hp_X] in 1 mL
Code: 789U1901C5
Classification: ACTIB
GLYPHOSATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 4632WW1X5A
Classification: ACTIB
IODINEActive
Quantity: 12 [hp_X] in 1 mL
Code: 9679TC07X4
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 12 [hp_X] in 1 mL
Code: C88X29Y479
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 12 [hp_X] in 1 mL
Code: E4GA8884NN
Classification: ACTIB
SELENIUMActive
Quantity: 12 [hp_X] in 1 mL
Code: H6241UJ22B
Classification: ACTIB
ZINCActive
Quantity: 12 [hp_X] in 1 mL
Code: J41CSQ7QDS
Classification: ACTIB
ASPARTAMEActive
Quantity: 30 [hp_X] in 1 mL
Code: Z0H242BBR1
Classification: ACTIB
BENZALKONIUM CHLORIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB
FORMALDEHYDE SOLUTIONActive
Quantity: 30 [hp_X] in 1 mL
Code: T0H3L6C7I5
Classification: ACTIB
METHYLPARABENActive
Quantity: 30 [hp_X] in 1 mL
Code: A2I8C7HI9T
Classification: ACTIB
PROPYLPARABENActive
Quantity: 30 [hp_X] in 1 mL
Code: Z8IX2SC1OH
Classification: ACTIB
SODIUM BENZOATEActive
Quantity: 30 [hp_X] in 1 mL
Code: OJ245FE5EU
Classification: ACTIB
TITANIUM DIOXIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB
ZINC OXIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: SOI2LOH54Z
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TARAXACUM OFFICINALEActive
Quantity: 3 [hp_X] in 1 mL
Code: 39981FM375
Classification: ACTIB
METHYLENE CHLORIDEActive
Quantity: 30 [hp_X] in 1 mL
Code: 588X2YUY0A
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMActive
Quantity: 30 [hp_X] in 1 mL
Code: 1Q73Q2JULR
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/13/2022

PACKAGE LABEL DISPLAY:

Dr. Donna Restivo DC
Wellness Consultant

NDC 62185-0065-1

HOMEOPATHIC
Insecticides & Pest & Food Additives DETOX

1 FL OZ (30 ml)

Insecticides & Pest & Food Additives Detox

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/13/2022

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, occasional diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/13/2022

ACTIVE INGREDIENTS:

Boldo 3X, Carduus Marianus 3X, Chelidonium Majus 3X, Petroselinum Sativum 3X, Taraxacum Officinale 3X, Arsenicum Album 12X, Bisphenol A 12X, Cobaltum Metallicum 12X, Cuprum Metallicum 12X, Glyphosate 12X, Iodium 12X, Lycopodium Clavatum 12X, Phosphoricum Acidum 12X, Selenium Metallicum 12X, Zincum Metallicum 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methyl Paraben 30X, Propyl Paraben 30X, Sodium Benzoate 30X, Sodium Citrate 30X, Titanium Dioxide 30X, Zincum Oxydatum 30X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/13/2022

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, occasional diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/13/2022

WARNINGS:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: Sealed for Your Protection. Do not use if seal is broken or missing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/13/2022

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/13/2022

DIRECTIONS:

10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/13/2022

INACTIVE INGREDIENTS:

demineralized water, 25% ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/13/2022

QUESTIONS:

Distributed by Dr. Donna Restivo DC, Wellness Consultant

822 South Lake Blvd, Mahopac, New York 10541

www.mahopacmassage.com • (845) 628-6286

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Insecticides/Pest/Food Additives Detox - FDA Drug Approval Details